FDA WARNING_LETTER - Texas Biostetic Instruments - November 18, 2014

On October 28, 2014, an FDA inspection of Texas Biostetic Instruments, LLC in Colleyville, Texas, revealed that the firm operates as an importer/initial distributor of four unapproved and misbranded medical devices: the Bio Lipo LED Machine, Biostetic Jet Peel Photodynamic Therapy (PDT) device, Biostetic 2100 Micro-current, and TBI-BIO-Light Tower LED Skin Rejuvenation System.

All four devices were found to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), for lacking an approved premarket approval (PMA) or investigational device exemption (IDE). They were also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), due to failure to submit premarket notifications (510(k)). The FDA determined that the firm incorrectly classified these devices as exempt from premarket notification, as they utilize different fundamental scientific technologies and/or have different intended uses than legally marketed devices in their claimed classifications (e.g., "nonmeasuring exercise equipment" or "daily activity assist devices").

Additionally, the firm's quality system was found to have nonconformities with current good manufacturing practice (CGMP) requirements